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NCT Number: NCT06201728

The Effect of Asthma Flare-up Clinic After Exacerbation

The goal of this interventional study is to examine the effect of asthma flare-up clinic follow-up in adult subjects after an asthma flare-up. This study aim to answer the following questions:

1. Does a follow-up in a flare-up clinic improves disease outcomes? 2. Does a follow-up in a flare-up clinic improves disease management?

Participants in the intervention group will take part in a structured follow-up at the asthma flare-up clinic at three time points. Each visit will include questionnaires, pulmonologist examination and consultation, laboratory tests and spirometry. The control group will undergo phone-call follow-up with a research coordinator in similar time frames as the intervention.

Researchers will compare the two groups to see if the clinic follow-up affects the study outcomes.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Asthma Asthma Attack Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

About this study

The primary outcomes will be analyzed as total exacerbations during the time frame and as a time-dependent variable (time to exacerbation) using Kaplan Meier survival analysis. Additional sub-analyses will be made for the type of inclusion setting (ED/hospitalization), number of prior exacerbations, and eosinophil count. Additional analyses will be made for all secondary outcomes. Analyses relevant only for the intervention group (such as spirometry and IOS) will compare results to the first follow-up visit. A cost-effectiveness analysis will be made, comparing the follow-up cost and the cost saved by exacerbation reduction based on the final results.

Sample size calculation - The invetigators assume based on previous research that the intervention will lead to a 20% decrease in exacerbations during the 12 months from first follow-up. To achieve an alpha of 0.05 and a power of 80%, there is a need for 88 patients in each group. Assuming a loss-to-follow-up rate (missing to complete at least 2 clinic visits or loss to phone follow-up) of 20%, the study will need 115 patients in each group (230 overall).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Prior asthma diagnosis based on clinical and spirometry accepted criteria.
  • Acute exacerbation of asthma as the main reason for ED arrival.
  • Ability to perform in-person and telephone follow-up.
  • Agree to participate, with a signed or verbal informed consent, according to the study group.

Exclusion criteria

  • Uncontrolled comorbidity.
  • Cognitive dysfunction.
  • Patients under 18 years or above 75 years.
  • Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, idiopathic pulmonary fibrosis, Churg-Strauss Syndrome, etc) which may impair lung function.

Treatment and study plan

Follow-up in a flare-up clinic

Other

Follow-up in the clinic based on the time frame specified above. Additional interventions during the clinic visit, other than specified above, includes: An overview by a pulmonologist of new exacerbations, systemic steroid use, or other hospitalizations, active medications and compliance to treatment, inhaler using technique, possible medication side-effects, and the asthma control test (ACT) score. The physician will provide information on smoking cessation when relevant and pulmonary rehabilitation. In addition, decision on change of treatment and further evaluations outside of the clinic, including initiation of biologic treatment.

Primary outcomes

  1. Exacerbations

    Time frame: During study follow-up (12 months from inclusion)

    The rate of severe asthma exacerbations between the intervention and control, defined as a deterioration of asthma leading to treatment for 3 days or more with systemic glucocorticoids or hospitalization or an emergency department visit leading to treatment with systemic glucocorticoids.

Secondary outcomes

  1. Hospital arrival

    Time frame: During study follow-up (12 months from inclusion)

    The rate of asthma exacerbations leading to hospital arrival between the intervention and control

  2. Systemic steroids

    Time frame: During study follow-up (12 months from inclusion)

    The rate of systemic steroids use between the intervention and control

  3. Asthma control score

    Time frame: During study follow-up (12 months from inclusion)

    Change in asthma control score between the intervention and control. Values range 5-25, with higher scores indicating better control.

  4. Quality of life score

    Time frame: During study follow-up (12 months from inclusion)

    Change in Asthma Quality of Life Questionnaire score in the intervention group. Values range 7-224, with higher scores indicating better quality of life

  5. Time to first exacerbation

    Time frame: During study follow-up (12 months from inclusion)

    Time to first asthma exacerbation between the intervention and control

  6. Time to first hospital arrival

    Time frame: During study follow-up (12 months from inclusion)

    Time to first hospital arrival due to asthma exacerbation and from any cause between the intervention and control

  7. Time to first systemic steroids use

    Time frame: During study follow-up (12 months from inclusion)

    Time to first systemic steroid use due to respiratory symptoms between the intervention and control

  8. Clinical remission

    Time frame: During study follow-up (18 months from inclusion)

    Rate of clinical remission for at least 12 months, defined as a period without exacerbations, need of systemic steroids, and an ACT above or equal to 20.

  9. Extended clinical remission

    Time frame: During study follow-up (18 months from inclusion)

    Rate of extended clinical remission for at least 12 months, defined as above, with additional spirometry criteria - FEV1 after bronchodilators equal/above 80% or increase of 100 ml of pre-bronchodilator FEV1 from baseline.

  10. Percentage of Participants with errors of inhaler use technique

    Time frame: During study follow-up (18 months from inclusion)

    Errors of inhaler use technique in the intervention group between clinic visits

  11. Percentage of Participants with a change in treatment

    Time frame: First clinic visit (1 month after inclusion)

    Change in treatment at the first clinic visit in the intervention group

  12. Adherent to treatment guidelines

    Time frame: During study follow-up (18 months from inclusion)

    Treatment adhere to the Global Initiative for Asthma (GINA) guidelines based on disease severity, in the intervention vs. the control.

  13. Percentage of Participants with treatment compliance

    Time frame: During study follow-up (18 months from inclusion)

    Compliance of inhaler treatment between the intervention and control

  14. Change in spirometry variables

    Time frame: During study follow-up (12 months from inclusion)

    Change in spirometry variables in the intervention group, including forced expiratory volume (FEV1) in liters and %predicted, Forced vital capacity (FVC) in liters and %predicted.

  15. Change in FeNO results

    Time frame: During study follow-up (12 months from inclusion)

    Change in exhaled nitric oxide test results (FeNO) in the intervention group, in parts per billion.

  16. Change in area of reactance using IOS

    Time frame: During study follow-up (12 months from inclusion)

    Change in the area of reactance (AX) using Impulse oscillometry.

  17. Change in resonant frequency using IOS

    Time frame: During study follow-up (18 months from inclusion)

    Change in the reactance resonant frequency (RF, measured in Hz) using Impulse oscillometry.

  18. Changes in respiratory resistance at 5 Hz, 20 Hz and the difference between 5 and 20 Hz using IOS

    Time frame: During study follow-up (12 months from inclusion)

    Change in respiratory resistance at 5 Hz (R5, measured in kPa/L/s) and 20 Hz (R20, measured in kPa/L/s), the difference between R5 and R20 (R5-R20, measured in kPa/L/s) using Impulse oscillometry.

  19. Changes in reactance at 5 Hz using IOS

    Time frame: During study follow-up (12 months from inclusion)

    Change in the reactance at 5 Hz (X5) using Impulse oscillometry.

Other outcomes

  1. asthma control test score - intervention

    Time frame: at inclusion and end of study among the intervention group.

    Asthma control test score. Values range 5-25, with higher scores indicating better control.

  2. Analysis according to absolute peripheral eosinophils count

    Time frame: During study follow-up (18 months from inclusion)

    Analysis of the primary outcome base on eosinophil levels above or below 300 and 150 (as measured prior to study inclusion without steroid treatment).

  3. Exacerbations - pre-post

    Time frame: comparison during the intervention to the similar time frame before inclusion

    The rate of severe asthma exacerbations, defined as a deterioration of asthma leading to treatment for 3 days or more with systemic glucocorticoids or hospitalization or an emergency department visit leading to treatment with systemic glucocorticoids.

  4. Systemic steroids - pre-post

    Time frame: comparison during the intervention to the similar time frame before inclusion

    The rate of systemic steroids use

  5. Hospital admission - pre-post

    Time frame: comparison during the intervention to the similar time frame before inclusion

    The rate of asthma exacerbations leading to hospital arrival between the intervention and control

  6. Post-HOC analysis - exacerbations

    Time frame: At the extended duration from clinic follow-up - at 18 months

    Asthma exacerbations between the intervention and control groups

  7. Post-HOC analysis - hospital arrival due to asthma exacerbation

    Time frame: At the extended duration from clinic follow-up - at 18 months

    Rate of hospital arrival due to asthma exacerbation between the intervention and control group

  8. Post-HOC analysis - ACT score

    Time frame: At the extended duration from clinic follow-up - at 18 months

    Changes in the Asthma control test score (ACT) between the intervention and control groups.

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Collaborators

  • AstraZeneca

Registry information

Official study title

The Role of Asthma Flare-up Clinic in Improving Management and Outcomes of Asthma

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 11, 2024
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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